Whom should I send the FSCA (Field Safety Corrective Action) to?

[Arnthor]

Dear all,

With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:

"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."

If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?

Best regards,

Arnthor

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

Stijloor.

[somashekar]

In Reply to Parent Post by Arnthor

Dear all,

With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:

"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."

If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?

Best regards,

Arnthor

Hii Arnthor...
If you are outside of the EU, please make your EU authorized representative the interface between you and the Authorities / NB, and he could do the needful. Send him the FSCA.

For Incidents occurring outside the EEA and Switzerland and do not lead to a Field Safety corrective action (FSCA) relevant to these geographic areas do not need to be Reported. For incidents occurring outside the EEA and Switzerland and led to a field Safety corrective action relevant to the above-mentioned geographical areas, the field safety corrective action is shared to the authorized representative who interfaces and submits the same to the appropriate Competent Authority, and to the notified body. Customers are notified via Field Safety Notice (FSN)

The above is an extract from our procedure...